Considering the importance of treating painful neuropathy in diabetic patients and the prevalence of this disease, it is necessary to find different therapies.
The aim of this study was to investigate the effect of low-power laser on the improvement of pain and quality of life in these patients in order to be able to
The effectiveness of this modality has been used to treat this disease
Design
In this Clinical trial, we investigated on 26 patients with De Quervain tenosynovitis who are eligible to treat, the intervention group was under treatment with extracorporeal shock wave (1000 impulse, 2 bar, and 15Hz) and placebo was under treatment without shock wave. The assessments tools were DISABILITIES OF THE ARM, SHOULDER, AND HAND (DASH) questionnaire, visual analog scale (VAS) and grip strength and used before and after treatment.
Settings and conduct
this is a double blind study which will be conducted in Isfahan, universities clinics in this city.
Participants/Inclusion and exclusion criteria
Patients with painful peripheral neuropathy older than 18 years of age
Consent to participate in this study.
Intervention groups
Patients treated with 8 sessions of low-power laser as 1 session
Placed per week) with a dose of 8 Jules per square centimeter on the back and foot of the foot, as well as in the popliteal area and on the head
Fibula bone (and in the control group of the laser), a silent device that does not produce effective doses (for 8 sessions in the areas.
Main outcome variables
improvement of the sign and symptoms of the patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043931N1
Registration date:2020-01-20, 1398/10/30
Registration timing:retrospective
Last update:2020-01-20, 1398/10/30
Update count:0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
Shila Haghighat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 5139
Email address
shila_haghighat@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of low level laser therapy on pain intensity and quality of life in patients with diabetic neuropathy
Public title
Role of low level laser therapy on pain intensity and quality of life in patients with diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with painful peripheral neuropathy older than 18 years of age
Willingness to participate in the research project (filling the consent letter)
Exclusion criteria:
malignancy
Active or untreated thyroid disease
Infection with other known neurological and masculo-skeletal disorders simultaneously in the lower extremity
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 patients with diabetic polyneuropathy (DNP) for 4 weeks would be enrolled in this double-blind randomized clinical trial. Patients will be randomized to receive placebo (sham laser) treatment (n = 20) or low level energy laser (n = 20). For randomization every patient will be pointed by a cod and after that every cod will be selected by provided randomization table. The score of VAS and SF36 will be evaluated in all of the patients in both groups immediately after, 2 and 4 weeks later.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the physician who evaluate the VAS criteria and SF36 forms of the patients (out put) will not know anything about the therapeutic method which is used for any patients. The method of therapy is also blind for patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib street,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
1396.3.036
Health conditions studied
1
Description of health condition studied
Painful diabetic neuropathy: Painful diabetic neuropathy (PDN) is a common and debilitating complication of both types of diabetes mellitus. With this disorder the patients’ sleep, mood, function and mainly quality of life (QOL) will be disturbed.
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Pain and quality of life in patients with diabetic neuropathy
Timepoint
Before the intervention, immediately, 1 week and 1 week after the end of treatment in each group
Method of measurement
Pain intensity using VAS criteria and quality of life using SF36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These patients will receive 8 sessions of low power laser. Treatments were administered twice weekly for 4 weeks.
Category
Rehabilitation
2
Description
Control group: These patients will recive 8 sessions of sham (non effectivee) laser. Treatments were administered twice weekly for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Physical medicine affiliated with the Isfahan medical sciences universities.
Full name of responsible person
Najmeh Zare Zardini
Street address
Al-Zahra hospital, Shohadaye Sofeh ave.,
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
zarenajme920@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan Universty of Medical Sciences,Hezar Jerib Ave.,
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Najmeh Zare Zardini
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
zarenajme920@gmaail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Najmeh Zare Zardini
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave.,
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
zarenajme920@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Najmeh Zare Zardini
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences,Hezar Jerib Ave.,
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
zarenajme920@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Starting the access period 6 months after printing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
No specific conditions.
From where data/document is obtainable
Contact the author and researcher
What processes are involved for a request to access data/document
By emailing or calling the author as soon as you respond to the data requestor, you can access the data